"These are serious and potentially life-threatening infections for which new treatment options are needed," Edward Cox, MD, MPH, director, Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research, said in a statement.

Ceftaroline was evaluated in four, phase III clinical trials in patients ages 18 years and older (two each in CABP and in ABSSSI). In the CABP trials, the comparator antibacterial treatment was ceftriaxone (Rocephin) and in the ABSSSI trials, the comparator antibacterial treatment was vancomycin (Vancocin) plus aztreonam (Azactam).

In the CABP trials, 1,231 adult patients received ceftaroline or ceftriaxone. Clinical response based on improvement in signs and symptoms of pneumonia on day four after starting therapy served as the key analysis endpoint. In both trials, the effectiveness of ceftaroline was comparable to ceftriaxone.

In the ABSSSI trials, 1,396 adult patients received ceftaroline or vancomycin plus aztreonam. Clinical response, including cessation of spread of the lesion and absence of fever on day three, served as the key analysis endpoint. Again ceftaroline demonstrated efficacy and safety comparable to the control arm.

The most commonly reported side effects in patients treated with ceftaroline included diarrhea, nausea, and rash. The drug should not be used in patients with sensitivities to cephalosporin antibiotics.

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